Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 and Metformin After Oral Administration in Healthy Male Subjects

November 25, 2013 updated by: Dong-A Pharmaceutical Co., Ltd.

A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 5 mg and Metformin IR 1000 mg After Oral Administration in Healthy Male Volunteers

This is a randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of DA-1229 5 mg and Metformin IR 1000 mg after oral administration in healthy male volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Clinical Trial Center, Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age between 20 to 45, healthy male subjects(at screening)
  • Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
  • FPG 70-125mg/dL glucose level(at screening)
  • Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

  • Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
  • Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
  • Subject who had drug(Aspirin, antibiotics) hypersensitivity reaction
  • Subject who already participated in other trials in 2 months
  • Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion in 1 months currently.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: D → M → D+M
D : DA-1229 5mg qd, M : metformin 1000mg bid
Drug: metformin
Drug: DA-1229
Drug: DA-1229 + metformin
Experimental: D → D+M → M
D : DA-1229 5mg qd, M : metformin 1000mg bid
Drug: metformin
Drug: DA-1229
Drug: DA-1229 + metformin
Experimental: M → D → D+M
D : DA-1229 5mg qd, M : metformin 1000mg bid
Drug: metformin
Drug: DA-1229
Drug: DA-1229 + metformin
Experimental: M → D+M → D
D : DA-1229 5mg qd, M : metformin 1000mg bid
Drug: metformin
Drug: DA-1229
Drug: DA-1229 + metformin
Experimental: D+M → M → D
D : DA-1229 5mg qd, M : metformin 1000mg bid
Drug: metformin
Drug: DA-1229
Drug: DA-1229 + metformin
Experimental: D+M → D → M
D : DA-1229 5mg qd, M : metformin 1000mg bid
Drug: metformin
Drug: DA-1229
Drug: DA-1229 + metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUCτ,ss of DA-1229 and metformin
Time Frame: up to 168h
up to 168h
Cmax,ss of DA-1229 and metformin
Time Frame: up to 168h
up to 168h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dong-A Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

September 9, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Estimate)

November 27, 2013

Last Update Submitted That Met QC Criteria

November 25, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA1229_DIM_I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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